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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number M5722INT0600220
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Code Available (3191)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
It was reported that the patient has femoral implant loosening.A revision surgery is planned to exchange the femoral implant and poly insert.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
It was reported that the patient has femoral implant loosening.A revision surgery is planned to exchange the femoral implant and poly insert.
 
Manufacturer Narrative
It was reported that the patient has femoral implant loosening.A revision surgery is planned to exchange the femoral implant and poly insert.Review of the device history record indicates that the device was manufactured to specification.Returned device evaluation: the explanted femoral implant was returned for evaluation.Evaluation of the explanted femoral implant indicates no signs of obvious wear or damage.The distal part of the implant where there are no undercuts appears to have grinded with the bone which resulted in a slight shine.From the information available, a conclusive statement cannot be made as to why this implant became loose.However, leftover cement present on the femoral implant and the faint shine of the distal femur portion of the implant suggest the loosening could have been related to the cementing technique.Issues with cementing technique can include not giving adequate time for the cement to set on the distal femur or implant used for trialing and not cleaned well prior to cementing.
 
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Brand Name
IUNI G2
Type of Device
UNICONDYLAR KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
Manufacturer (Section G)
CONFORMIS, INC.
600 research dr.
wilmington MA 01887
Manufacturer Contact
karina snow
600 technology park drive
billerica, MA 01821
7813459195
MDR Report Key6793699
MDR Text Key82660656
Report Number3004153240-2017-00177
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K133256
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date04/30/2016
Device Catalogue NumberM5722INT0600220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
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